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Fascia Iliaca Compartment Block for Proximal-end Femur Fractures

4. marts 2016 opdateret af: Mansoura University

Fascia Iliaca Compartment Block in Proximal End Femur Fractures, Does it Make a Difference?

Fracture femur is a common injury which is associated with excruciating pain. Positioning for neuraxial blocks is always challenging because even slight overriding of the fracture ends is intensely painful .It can causing major patient distress which accompanied by well-known physiological sequelae such as sympathetic activation causing tachycardia, hypotension, and increased cardiac work that may compromise high-risk cardiac patients.

Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but it is also associated with minimal risk as the local anesthetic is injected at a safe distance from the femoral artery and femoral nerve. It is always safe to perform the fascia iliaca compartment block prior to spinal anesthesia as the patient can respond during administration of the local anesthetic and can prevent intra-neuronal injections

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

On arrival to the pre-operative holding area half hour before the scheduled surgery. Patient will be connected to basal monitoring devices; pulse oximetry and non- invasive blood pressure. Fascia iliaca compartment block will be performed with the aid of ultrasound device in all cases.The injected local anesthetic solution will be prepared by a staff member who was not involved in the study) according to the randomization. After 20 minutes from the injection the investigators will assessed nerves that had been blocked.

On arrival to the operative theater, under complete aseptic technique spinal anesthesia will be carried out in the sitting position (if there is severe pain at positioning we will use lateral position) at space between L3-4 or L4-5 using a 25-gauge spinal quincke needle. After feeling the desired space, the needle will be advanced (paramedian approach) till free flow of cerebrospinal fluid dropped from the needle then 15 mg hyperbaric bupivacaine+20mic fentanyl will be injected.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
    • DK
      • Mansoura, DK, Egypten, 050
        • Mansoura University Hospitals

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • American Society of Anesthesiologist physical status I to III
  • Patients scheduled for fixation for proximal end femur fracture

Exclusion Criteria:

  • Patients refusal
  • Morbid obese patients (BMI>40)
  • Bleeding diathesis
  • Previous femoral bypass surgery
  • Inguinal hernia
  • Inflammation/infection over injection site
  • Peripheral neuropathy
  • Allergy to local anesthetics agents used.
  • Severely altered consciousness level
  • Psychiatric disorders
  • Polytrauma

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.
Medicin: Placebo
Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml
Enhed: Ultrasound guided fascia iliaca compartment block
Ultrasound guided fascia iliaca compartment block
Medicin: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)
Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms
Aktiv komparator: Bupivacaine
Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.
Enhed: Ultrasound guided fascia iliaca compartment block
Ultrasound guided fascia iliaca compartment block
Medicin: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)
Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms
Medicin: Bupivacaine
Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain scores
Tidsramme: For 24 hours after performance the blockade
Pain was assessed using visual analogue score
For 24 hours after performance the blockade

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart rate
Tidsramme: For 24 hours after performance the blockade
For 24 hours after performance the blockade
Blood pressure
Tidsramme: For 24 hours after performance the blockade
For 24 hours after performance the blockade
Peripheral oxygen saturation
Tidsramme: For 24 hours after performance the blockade
For 24 hours after performance the blockade
Time to performing spinal anesthesia
Tidsramme: For 30 min after placement of patient in the optimum position
Time from the placement of patient in the optimum position to the intra-thecal injection of bupivacaine
For 30 min after placement of patient in the optimum position
Number of trials of dural puncture
Tidsramme: For 30 min after placement of patient in the optimum position
For 30 min after placement of patient in the optimum position
Duration of motor blockade
Tidsramme: For 12 hours after performing spinal anesthesia
For 12 hours after performing spinal anesthesia
Duration of sensory blockade
Tidsramme: For 12 hours after performing spinal anesthesia
For 12 hours after performing spinal anesthesia
Duration of analgesia
Tidsramme: For 24 hours after performing spinal anesthesia
Time from performing spinal anesthesia to first analgesic request
For 24 hours after performing spinal anesthesia
Cumulative consumption of analgesics
Tidsramme: For 24 hours after performing spinal anesthesia
Total opioid or other analgesics received for the first 24 hours after surgery.
For 24 hours after performing spinal anesthesia

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mansoura University

Efterforskere

  • Studiestol: Reem A El Sharkawy, MD, Lecturer of Anesthesia and Surgical Intensive care

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2015

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

22. februar 2016

Først indsendt, der opfyldte QC-kriterier

1. marts 2016

Først opslået (Skøn)

2. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MS/811

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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